Hydrocortisone butyrate 0.1% lotion in the treatment of atopic dermatitis in pediatric subjects.

Robert Matheson, Steven Kempers, Debra Breneman, Zoe Draelos, Candice E Johnson, Robert Loss, Daniel J Hogan, Robert Schoenfeld, Scott Checketts, Leon Kircik, David Fivenson, Adelaide A Hebert, Judith Williams, Regina Hamlin, Daniel Groisser, Dan Piacquadio

Index: Journal. of. Drugs in. Dermatology. 7(3) , 266-71, (2008)

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Abstract

Hydrocortisone butyrate (HCB) is currently marketed as a cream, ointment, and solution. A new lotion formulation of hydrocortisone butyrate 0.1% (Locoid lotion) has been developed and evaluated.The objective of this study was to evaluate the efficacy and safety of HCB 0.1% lotion compared to the vehicle in subjects aged 3 months to less than 18 years with mild to moderate atopic dermatitis (AD).In this multicenter double-blind study, 284 subjects with mild to moderate AD were randomized 1:1 to receive HCB 0.1% lotion or the vehicle for a duration of 4 weeks. "Treatment success" was defined as those subjects with a final Physician Global Assessment (PGA) score of 0 or 1 that had at least a 2-point reduction in the PGA score from baseline to day 29. Safety was assessed by monitoring adverse events.Analyses of the final PGA score showed a significant treatment effect (P <.001) in favor of the HCB 0.1% lotion group. The safety profile of the HCB 0.1% lotion was also favorable.The study did not assess the durability of the treatment effects (ie, safety and efficacy) after completion of the 4-week treatment period nor the potential need for longer term therapy given the chronic nature of AD.Results demonstrate the safety and efficacy of HCB 0.1% lotion in the treatment of mild to moderate AD in children 3 months to 18 years of age.